ISOSTATION KNEE MACHINE (K-100)
FDA 510(k) clearance K854621 · decided 1986-03-07
Clearance details
- K-number
- K854621
- Device name
- ISOSTATION KNEE MACHINE (K-100)
- Applicant
- Isotechnologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-18
- Decision date
- 1986-03-07
- Days to decision
- 109 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Hillsborough, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Isotechnologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.